MAUDE MDR 2764760

MDR report key
2764760
Report number
2432235-2012-00322
Event key
0
Event type
3
Date of event
2012-08-31
Date received
2012-09-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MINDY LOSAPIO
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMMULITE 2000 ERYTHROPOIETINIMMULITE 2000 XPISIEMENS HEALTHCARE DIAGNOSTICSGGTIMMULITE 2000 XPI318 & 319N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-280

Event Narratives#

D

Patient 1

DISCORDANT ERYTHROPOIETIN (EPO) RESULTS WERE OBTAINED ON 2 SAMPLES FROM THE SAME PATIENT ON THE IMMULITE 2000 XPI INSTRUMENT, WHERE DILUTED RESULTS DID NOT MATCH THE NEAT VALUES. THE INITIAL RESULT (NEAT) WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT AND REQUESTED A DILUTION. THE CUSTOMER PERFORMED ONE MANUAL DILUTION FOLLOWED BY SERIAL DILUTIONS, AND THEN OBTAINED A SECOND SAMPLE TUBE FROM THE PATIENT AND REPEATED THE SAME PROCESS USING A DIFFERENT REAGENT LOT. THE CUSTOMER DID NOT REPORT OUT ANY OF THE RERUN RESULTS, AND STATED THAT THEY WOULD DISCUSS THE RESULTS WITH THE PHYSICIAN TO DETERMINE IF THE SAMPLE SHOULD BE SENT TO AN ALTERNATE LABORATORY. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EPO RESULT.

N

Patient 1

A SIEMENS FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE CUSTOMER SITE BECAUSE THE CUSTOMER DECLINED SERVICE. BASED UPON THE RESULTS, THE CUSTOMER STATED THAT THEY BELIEVED THE ISSUE WAS SAMPLE SPECIFIC. THE CAUSE OF THE DISCORDANT EPO RESULTS IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR FURTHER TESTING.